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The Efficacy of the Whisperflow CPAP System Versus Nasal High Flow in Patients at High Risk for Postextubation Failure

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ClinicalTrials.gov Identifier: NCT02918786
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Pongdhep Theerawit, Ramathibodi Hospital

Brief Summary:
The purpose of this study is to compare the effect of continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula oxygen therapy in mechanically ventilated patient who are at risk for postextubation failure.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Nasal high-flow Device: CPAP Not Applicable

Detailed Description:

Postextubation respiratory failure is not an uncommon condition after discontinuation of mechanical ventilation. Subsequently reintubation and mechanical ventilation for postextubation respiratory failure may lead to increasing of hospital morbidity and mortality and and prolonging intensive care and hospital stay. Several studies have demonstrated the efficacy of non-invasive ventilation to prevent the postextubation failure in patients with high risk for extubation failure.

The variable generator whisper flow system ((Philips Respironics, Murrysville, PA, USA) is the one of widely used continuous positive airway pressure(CPAP) device in UK. This device employs an oxygen-driven venturi to entrain air and generates high fresh gas flow up to 140 liter per minute. The oxygen/air mixture enters the breathing circuit and exits through a threshold resistor namely CPAP valve. Whisperflow is able to provide the flow into the breathing system via oronasal mask which exceeds the peak inspiratory flow rate of the patient and may improve work of breathing as well as gas exchange. In daily clinical practice, the investigators apply this device with humidifier in patients with weaning difficulty and patients who are at risk for postextubation failure.

High-flow nasal oxygen therapy(HFNO) is a device which heated and humidified oxygen is distributed to the nose at high flow rates. With the high flow rate (up to 60 Liter per minute), it generates low level of positive airway pressure. Physiological benefits of HFNO comprises decreasing of the dead space, work of breathing and the low level of positive airway pressure associated with better lung recruitment. Furthermore, the fraction of inspired oxygen can be adjusted and measured by changing the fraction of oxygen in the driving gas.

In the present randomized, controlled trial, the investigators will compare two devices for oxygen therapy, with low levels of continuous positive airway pressure, nasal high-flow oxygen therapy and CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System with oronasal mask , in critically ill patients who are at risk for postextubation failure. The investigators hypothesize that nasal high-flow is superior to CPAP the in terms of reintubation rate.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Efficacy of the Whisperflow CPAP System Versus High Flow Nasal Cannula Oxygen Therapy in Patients at High Risk for Postextubation Failure
Study Start Date : February 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continuous positive airway pressure
After extubation, patients will receive continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System (control) Intervention:Device : CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System for 48 hours
Device: CPAP
After extubation, patients will receive CPAP at 5 cmH2O delivered by the variable generator WhisperFlow System. The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients.

Active Comparator: Nasal high-flow
After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention) Intervention: Device: Nasal high-flow
Device: Nasal high-flow
After extubation, the patients will receive oxygen delivered through the nasal high-flow system (Optiflow™). The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. Gas flow will be set until maximal level of 60 LPM.




Primary Outcome Measures :
  1. Reintubation rate [ Time Frame: 48 hours ]
    Number of participants who required reintubation within 48 hours after extubation


Secondary Outcome Measures :
  1. post extubation respiratory failure [ Time Frame: 48 hours ]
    Number of participants who required either reintubation or application of Bi-level noninvasive positive airway pressure within 48 hours after extubation


Other Outcome Measures:
  1. Length of ICU stay [ Time Frame: 30 days ]
  2. Patient's discomfort [ Time Frame: 48 hours ]
    The investigators will assessed the discomfort of participants by Critical-Care Pain Observation Tool.

  3. oxygen desaturations [ Time Frame: 48 hours ]
    The participants will be monitored and recorded oxygen saturation with the pulse oximeter at 15 minutes, 2 hours, 24 hours and 48 hours after extubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mechanical ventilation > 48 hours and
  • high risk for extubation failure namely , congestive heart failure, ineffective cough and excessive tracheobronchial secretions, more than one failure of a weaning trial, more than one co-morbid condition, patients who had hypercapnia, and upper airway obstruction without immediately required intubation

Exclusion Criteria:

  • age<18 years
  • pregnancy
  • tracheostomy
  • uncontrolled cardiac ischemia or arrhythmias
  • unstable hemodynamic status
  • documented swallowing problem
  • documented cervical spine injury
  • Facial anatomical abnormalities interfering with the mask fit
  • agitated or uncooperative state
  • lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918786


Contacts
Contact: Pongdhep Theerawit, MD 662011619 pongdhep.the@mahidol.ac.th

Locations
Thailand
Ramathibodi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Pongdhep Theerawit, MD    662011619    pongdhep.the@mahidol.ac.th   
Contact: Yuda Sutherasan, MD    662011619    sutherasan_yuda@yahoo.com   
Sub-Investigator: Yuda Sutherasan, MD         
Principal Investigator: Pongdhep Theerawit, MD         
Sub-Investigator: Nattawat Nudphobsuk, MD         
Sponsors and Collaborators
Ramathibodi Hospital

Publications:
Responsible Party: Pongdhep Theerawit, Assistant Professor, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT02918786     History of Changes
Other Study ID Numbers: ID 12-58-11
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Pongdhep Theerawit, Ramathibodi Hospital:
oxygen therapy
continuous positive airway pressure
extubation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases